Major Depressive Disorder (MDD)Phase 2KET01-IIT03NCT07396272
A Clinical Trial of Add-on Oral Slow-release Ketamine Treatment in Major Depression
A Phase 2 study testing Treatment with Ketamine Hydrochloride Prolonged-Release Tablets in people with Major Depressive Disorder (MDD), run by Daniel Lindqvist at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to explore if the treatment with ketamine tablets in addition to standard antidepressant therapy can reduce depressive symptoms in adults with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Treatment with Ketamine Hydrochloride Prolonged-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 13 Mar 2026to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given their written consent to participate in the trial.
- BMI ≥ 18 and ≤ 35 kg/m2.
- Primary diagnosis of MDD meeting DSM-5-TR criteria and one of the following episode characteristics: (a)MDD, single episode, moderate (ICD-10-CM: F32.1); (b) MDD, single episode, severe, without psychotic features (ICD-10-CM: F32.2); (c) MDD, recurrent, moderate (ICD-10-CM: F33.1); (d) MDD, recurrent, severe, without psychotic features (ICD-10-CM: F33.2)
- Duration of current depressive episode no longer than 12 months prior to screening.
- MADRS score ≥ 22 at screening
- Willingness to start a new, conventional antidepressant treatment which is chosen by the treating physician with regards to side effect profile and previous treatments, together with KET01, dosed according to the prescribed schedule.
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- Willingness to terminate any ongoing antidepressant treatment if deemed ineffective by study physician in accordance with clinical practice (tapering or immediate stop), followed by a wash-out phase of at least 7 days without medication before treatment with the new antidepressant is initiated together with KET01.
- For females of childbearing potential: Must be willing to undergo pregnancy tests and will be required to use highly effective contraceptive measures from the time of informed consent until 28 days after last IMP intake. Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral or injectable); implantable intrauterine device (IUD); intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or practicing sexual abstinence (if this is in line with the preferred and usual lifestyle of the participant).
- For male participants with a partner of childbearing potential: Must be willing to use adequate contraceptive measures (barrier method) or practice sexual abstinence (if this is in line with the preferred and usual lifestyle of the participant) from the time of informed consent until 28 days after last IMP intake. Note: These requirements also apply for male participants who have had a vasectomy.
Who cannot join
- Known hypersensitivity or intolerance to ketamine or any of the excipients.
- Pregnancy, breastfeeding or planned pregnancy (if female).
- High suicide risk according to the overall assessment of the research physician.
- Known psychiatric and neurological concomitant condition of:
- MDD, single episode, severe, with psychotic features (ICD-10-CM: F32.3), MDD, recurrent, severe, with psychotic features (ICD-10-CM: F33.3), Schizophrenia spectrum and other psychotic disorders (ICD-10-CM: F21, F22, F23, F20.81, F20.9, F25.0, F25.1, F06.0, F06.1, F06.2, F28 and F29) or bipolar disorder (ICD-10-CM: F31), other mental disorder due to known physiological condition (ICD-10-CM: F06). Participants with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders are also not considered eligible. Paranoid or schizoid personality disorder (ICD-10-CM: F60.0, F60.1). Antisocial, borderline, histrionic or narcissistic personality disorder (ICD-10-CM: F60.2, F60.3, F60.4, F60.81). Neurodevelopmental disorders, e.g. moderate to profound intellectual developmental disorders (ICD-10-CM: F71, F72, F73), or autism spectrum disorders (ICD-10-CM: F84).
- Known or suspected lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder, epilepsy (excluding uncomplicated childhood febrile seizures with no sequelae) or any other disease/procedure/accident/intervention which, according to the investigator is deemed associated with significant injury to or malfunction of the CNS.
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- History of significant head trauma within the past 2 years prior to Visit 1.
- History of cerebrovascular event (e.g. stroke, prolonged ischaemic neurologic deficit [PRIND], transient ischaemic attack).
- Known or suspected ongoing cardiac disease (e.g. unstable angina, congestive heart failure, tachyarrhythmia or myocardial infarction).
- Clinically significant abnormal electrocardiogram findings at Visit 1 which may jeopardize participant's safety according to the investigator.
- Untreated or uncontrolled hypertension (after 5 minutes of rest, systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 120 mmHg confirmed by three sequential measurements with at least 5 minutes between the single measurements).
- Laboratory findings suggesting impaired hepatic function or liver cirrhosis i.e. gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2x times the upper limit of normal (ULN) or total bilirubin > 1.5 times the ULN at Visit 1. Participants with an isolated increase of indirect bilirubin not previously documented as a diagnosis of Gilbert's syndrome must be discussed with the medical monitor.
- Known hepatitis B or C.
- eGFR < 60 mL/min/1.73 m2 or creatinine > 200 μmol/L at Visit 1 or ongoing dialysis or kidney transplants.
- Diabetes mellitus with a haemoglobin A1c (HbA1c) value > 64 mmol/mol at the screening visit.
- Hyperthyroidism.
- Uncontrolled hypothyroidism i.e. not at stable treatment with thyroid hormones (triiodothyronine/thyroxine [T3/T4]) within the 6 weeks before Visit 1 or abnormal thyroid stimulating hormone (TSH) and free thyroxine (fT4) values at Visit 1.
- History (within 5 years before Visit 1) of complicated cystitis (defined as cystitis in males; due to anatomical abnormalities; due to immunocompromised state, in pregnant women; recurrent infections despite adequate treatment; infections occurring after instrumentation such as nephrostomy).
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or jeopardise the conduct of the trial according to the protocol.
- Previous administration of ketamine (with exception of known or suspected ketamine-anaesthesia) or esketamine.
- Prohibited prior and concomitant therapies and medication (see 7.3 Concomitant use of other medicinal products and treatments).
- History of moderate to severe alcohol use disorder or substance use disorder, including e.g. benzodiazepines, opiates, ketamine, hallucinogens and related drugs, stimulants (e.g. phencyclidine [PCP]), lysergic acid diethylamide [LSD], 3,4-methylenedioxymethamphetamine [MDMA], dextromethorphan, amphetamines, cocaine) or cannabis, except nicotine and caffeine, within 6 months before Visit 1 or a positive drug abuse test except for allowed medication prescribed for a medical condition.
- Participation in other treatment studies.
- Ongoing electroconvulsive treatment (ECT) or repetitive transcranial magnetic stimulation (rTMS).
- Ongoing compulsory psychiatric care.
- Other reason, as assessed by the investigator, that prevents the research subject's participation such as risk that the subject is unable to complete the trial (non-compliance).
- Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open-label Phase II Trial of Adjunctive Treatment With Ketamine Hydrochloride Prolonged-Release Tablets (KET01) During the Initiation of Antidepressant Therapy in Major Depressive Disorder
- The goal of this clinical trial is to explore if the treatment with ketamine tablets in addition to standard antidepressant therapy can reduce depressive symptoms in adults with Major Depressive Disorder. The main question it aims to answer is: Does adjunctive ketamine therapy reduce depressive symptoms after one week of treatment compared to baseline, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)?
- Participants will start ketamine treatment together with a new standard antidepressant. During the treatment week, patients will receive four doses of Ketamine Hydrochloride Prolonged-Release Tablets (240 mg) at the clinic. They will fill in different questionnaires and rating scales during screening, treatment and follow-up, and will leave blood samples at five of the visits to monitor side effects and identify possible biomarkers. After a week, the ketamine treatment is finished while the standard antidepressant therapy continues. The participation in this trial is completed after three aditional weeks of follow-up.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Treatment with Ketamine Hydrochloride Prolonged-Release Tablets
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Ketamine Hydrochloride Prolonged-Release TabletsDrug
Only intervention of this pilot study, administered to all 12 patients enrolled. Treatment with Ketamine Hydrochloride Prolonged-Release Tablets (KET01, 240 mg) for one week (8 days) with four doses.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-treated | Experimental | Only arm of this pilot study, all 12 patients enrolled will be included in this arm. Treated with Ketamine Hydrochloride Prolonged-Release Tablets (KET01, 240 mg) for one week (8 days) with four doses. Receives: Drug: Treatment with Ketamine Hydrochloride Prolonged-Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) after one week of treatment compared to baseline visit
- In MADRS, 10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression.
- Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.
Measured: Between day 1 (baseline visit) and day 8 (day of last dosing)
Secondary outcomes (23)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score at other timepoints than the primary endpoint
- In MADRS, 10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression.
- Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.
Measured: Between day 1 (baseline visit) and visits on day 3, 5, 15 and 29
Change in Clinical Global Impression - Severity (CGI-S) rating scale from baseline to every post-baseline measurement (day 3, 5, 8, 15, 29)
In CGI-S, the overall illness severity is rated from 1 to 7:
- 1: Normal, not at all ill
- 2: Borderline mentally ill
- 3: Mildly ill
- 4: Moderately ill
- 5: Markedly ill
- 6: Severely ill
- 7: Among the most extremely ill patients
Measured: Between day 1 (baseline visit) and visits on day 3, 5, 15 and 29
Total score of Clinical Global Impression - Efficacy Index (CGI-E) rating scale at every post-baseline measurement (day 3, 5, 8, 15, 29)
The CGI-E is rated using a 4 × 4 matrix, consisting of:
Therapeutic Effect:
1 = Marked; 2 = Moderate; 3 = Minimal; 4 = None
Side Effects:
1 = None; 2 = Do not significantly interfere with functioning; 3 = Significantly interfere with functioning; 4 = Overwhelming and intolerable The CGI-E result is recorded as a paired score (e.g., 2:1, indicating a moderate therapeutic effect with no adverse effects). Investigators should base their evaluation on all available clinical information, including observed symptom changes, participant-reported outcomes, and the nature and impact of any adverse events.
Measured: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Change in Patient Health Questionnaire-9 (PHQ-9) and the composite inflammatory depressive symptom score (InfDep score) consisting of PHQ-9 items # 3, 4 and 5 between baseline (day 1) and the two follow-up visits (day 15 and 29)
In PHQ-9, 9 items are rated with a score of 0 to 3 from being experienced never (0) to almost every day (3) during the last 2 weeks (total score: 0 to 27). A higher PHQ-9 score indicates more severe depression. Cut-off points: 0-4: None to minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, 20-27: Severe depression
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in generalized anxiety disorder-7 (GAD-7) between baseline (day 1) and two follow-up visits (day 15 and 29)
In GAD-7, 7 items are rated with a score of 0 to 3 from being experienced never (0) to almost every day (3) during the last 2 weeks (total score: 0 to 27). A higher GAD-7 score indicates more severe anxiety. Cut-off points: 0-4: No to low anxiety, 5-9: Mild anxiety, 10-14 Moderate anxiety, 15+ Severe anxiety.
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in Columbia Suicide Severity Rating Scale (C-SSRS) between baseline and three post-baseline visit (day 8, 15, 29)
In C-SSRS, suicidality is mapped by yes/no questions and rating scales from 1 to 5. The higher the score on these scales, the more severe is the suicidality.
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Response rate (≥ 50% decrease from baseline in MADRS total score) at every post-baseline visit (day 3, 5, 8, 15, 29).
- In MADRS, 10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression.
- Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.
Measured: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Remission rate (MADRS score of ≤10) at every post-baseline visit (day 3, 5, 8, 15, 29).
- In MADRS, 10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression.
- Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.
Measured: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Change in sedentary behaviour (SED) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of determining physical activity measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in light physical activity (LPA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of determining physical activity measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in moderate- to vigorous physical activity (MVPA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of determining physical activity measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in number of steps between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of determining physical activity measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in total sleep time (TST) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in sleep efficiency (SE) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in wake after sleep onset (WASO) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in number of awakenings (NA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Parameter is part of analysing changes in sleep pattern measured by wearable activity meters
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Concentration of the inflammatory biomarker high-sensitive C-reactive protein in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Measured: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker interleukin-6 in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Measured: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker tumor necrosis factor alpha in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Measured: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker white blood cell count in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Measured: Between baseline visit (day 1) and last follow-up visit (day 29).
Change in Connor-Davidsson Resilience Scale (CD-RISC-25) between baseline (day 1) and two post-baseline visits (day 8 and 29)
In CD-RISC-25, 25 statements are rated with a score of 0 to 4 from being not true at all (0) to true almost all the time (4) (total score: 0 to 100). A higher CD-RISC-25 score indicates higher resilience.
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in genomic DNA methylation patterns between baseline and two post-baseline visits (day 8 and day 29).
Genomic DNA for DNA methylation analysis will be purified from whole blood using a commercially available kit. DNA methylation will be assessed using the Infinium MethylationEPIC v2.0 BeadChip array, covering > 900 000 unique methylation sites. Quality metrics will include assessment of bisulfite conversion efficiency using built-in control probes, evaluation of overall signal intensities across samples, and identification of outlier samples through inspection of quality control (multidimensional scaling) plots. Probes will be filtered to remove those with detection p-value >0.01 in >5% of samples, probes with known single nucleotide polymorphisms (SNPs) at the CpG interrogation site or single base extension site, cross-reactive probes that map to multiple genomic locations. For differential methylation analysis, β-values will be transformed to M values using logit transformation to stabilise variance and approximate normality.
Measured: Between baseline visit (day 1) and last follow-up visit (day 29)
Patient's personal experience with effect of ketamine treatment on mood
Qualitative interview with open-ended question
Measured: At the last follow-up (day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start13 Mar 2026
- Primary completion6 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Lindqvist
- Sponsor type
- University, hospital or other
- Collaborators
- Ketabon, Lund University
- Responsible party
- Sponsor-investigator, Daniel Lindqvist, Region Skane
- Investigators
- Daniel Lindqvist, PhD, MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396272
- Sponsor's protocol ID
- 2025-524841-28-00
- Other IDs
- 2025
- Acronym
- KET01-IIT03
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-label Phase II Trial of Adjunctive Treatment With Ketamine Hydrochloride Prolonged-Release Tablets (KET01) During the Initiation of Antidepressant Therapy in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT07396272
- Acronym / sponsor ID
- KET01-IIT03 / 2025-524841-28-00
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Daniel LindqvistUniversity, hospital or other
- Collaborators
- Ketabon, Lund University
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The goal of this clinical trial is to explore if the treatment with ketamine tablets in addition to standard antidepressant therapy can reduce depressive symptoms in adults with Major Depressive Disorder. The main question it aims to answer is: Does adjunctive ketamine therapy reduce depressive symptoms after one week of treatment compared to baseline, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)?
- Participants will start ketamine treatment together with a new standard antidepressant. During the treatment week, patients will receive four doses of Ketamine Hydrochloride Prolonged-Release Tablets (240 mg) at the clinic. They will fill in different questionnaires and rating scales during screening, treatment and follow-up, and will leave blood samples at five of the visits to monitor side effects and identify possible biomarkers. After a week, the ketamine treatment is finished while the standard antidepressant therapy continues. The participation in this trial is completed after three aditional weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine-treated | Experimental | Drug: Treatment with Ketamine Hydrochloride Prolonged-Release TabletsOnly arm of this pilot study, all 12 patients enrolled will be included in this arm. Treated with Ketamine Hydrochloride Prolonged-Release Tablets (KET01, 240 mg) for one week (8 days) with four doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject has given their written consent to participate in the trial.
- BMI ≥ 18 and ≤ 35 kg/m2.
- Primary diagnosis of MDD meeting DSM-5-TR criteria and one of the following episode characteristics: (a)MDD, single episode, moderate (ICD-10-CM: F32.1); (b) MDD, single episode, severe, without psychotic features (ICD-10-CM: F32.2); (c) MDD, recurrent, moderate (ICD-10-CM: F33.1); (d) MDD, recurrent, severe, without psychotic features (ICD-10-CM: F33.2)
- Duration of current depressive episode no longer than 12 months prior to screening.
- MADRS score ≥ 22 at screening
Key exclusion criteria (27 listed)
- Known hypersensitivity or intolerance to ketamine or any of the excipients.
- Pregnancy, breastfeeding or planned pregnancy (if female).
- High suicide risk according to the overall assessment of the research physician.
- Known psychiatric and neurological concomitant condition of:
- MDD, single episode, severe, with psychotic features (ICD-10-CM: F32.3), MDD, recurrent, severe, with psychotic features (ICD-10-CM: F33.3), Schizophrenia spectrum and other psychotic disorders (ICD-10-CM: F21, F22, F23, F20.81, F20.9, F25.0, F25.1, F06.0, F06.1, F06.2, F28 and F29) or bipolar disorder (ICD-10-CM: F31), other mental disorder due to known physiological condition (ICD-10-CM: F06). Participants with first-degree relatives (parents, brothers, sisters or children) with psychotic or bipolar disorders are also not considered eligible. Paranoid or schizoid personality disorder (ICD-10-CM: F60.0, F60.1). Antisocial, borderline, histrionic or narcissistic personality disorder (ICD-10-CM: F60.2, F60.3, F60.4, F60.81). Neurodevelopmental disorders, e.g. moderate to profound intellectual developmental disorders (ICD-10-CM: F71, F72, F73), or autism spectrum disorders (ICD-10-CM: F84).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with Ketamine Hydrochloride Prolonged-Release TabletsOnly intervention of this pilot study, administered to all 12 patients enrolled. Treatment with Ketamine Hydrochloride Prolonged-Release Tablets (KET01, 240 mg) for one week (8 days) with four doses. | Drug | Ketamine-treated |
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) after one week of treatment compared to baseline visit
Time frame: Between day 1 (baseline visit) and day 8 (day of last dosing)
* In MADRS, 10 items are rated with a score of 0 to 6 (total score: 0 to 60). A higher MADRS score indicates more severe depression. * Cut-off points: 0 to 6: normal/symptom-free, 7 to 19: mild depression, 20 to 34: moderate depression 35 to 60: severe depression.
23 secondary outcomes
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score at other timepoints than the primary endpoint
Time frame: Between day 1 (baseline visit) and visits on day 3, 5, 15 and 29
Change in Clinical Global Impression - Severity (CGI-S) rating scale from baseline to every post-baseline measurement (day 3, 5, 8, 15, 29)
Time frame: Between day 1 (baseline visit) and visits on day 3, 5, 15 and 29
Total score of Clinical Global Impression - Efficacy Index (CGI-E) rating scale at every post-baseline measurement (day 3, 5, 8, 15, 29)
Time frame: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Change in Patient Health Questionnaire-9 (PHQ-9) and the composite inflammatory depressive symptom score (InfDep score) consisting of PHQ-9 items # 3, 4 and 5 between baseline (day 1) and the two follow-up visits (day 15 and 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in generalized anxiety disorder-7 (GAD-7) between baseline (day 1) and two follow-up visits (day 15 and 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in Columbia Suicide Severity Rating Scale (C-SSRS) between baseline and three post-baseline visit (day 8, 15, 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Response rate (≥ 50% decrease from baseline in MADRS total score) at every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Remission rate (MADRS score of ≤10) at every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between first evaluation after treatment start (day 3) and last follow-up visit (day 29)
Change in sedentary behaviour (SED) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in light physical activity (LPA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in moderate- to vigorous physical activity (MVPA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in number of steps between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in total sleep time (TST) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in sleep efficiency (SE) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in wake after sleep onset (WASO) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in number of awakenings (NA) between baseline (day 1) and every post-baseline visit (day 3, 5, 8, 15, 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Concentration of the inflammatory biomarker high-sensitive C-reactive protein in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker interleukin-6 in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker tumor necrosis factor alpha in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29).
Concentration of the inflammatory biomarker white blood cell count in the blood plasma at baseline (day 1) and three post-baseline visits (day 8, 15, 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29).
Change in Connor-Davidsson Resilience Scale (CD-RISC-25) between baseline (day 1) and two post-baseline visits (day 8 and 29)
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Change in genomic DNA methylation patterns between baseline and two post-baseline visits (day 8 and day 29).
Time frame: Between baseline visit (day 1) and last follow-up visit (day 29)
Patient's personal experience with effect of ketamine treatment on mood
Time frame: At the last follow-up (day 29)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lindqvist, PhD, MD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment with Ketamine Hydrochloride Prolonged-Release Tablets in people with Major Depressive Disorder (MDD), run by Daniel Lindqvist at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) after one week of treatment compared to baseline visit (time frame: Between day 1 (baseline visit) and day 8 (day of last dosing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.